MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-13 for A CORD MH-969 NA manufactured by Olympus Medical Systems Corporation.
[4556638]
Olympus medical systems corp (omsc) was informed that during polypectomy of colon the doctor got an error trying to activate output while he snared the target polyp and output could not be activated. Then he noticed that the subject product broke. He exchanged the subject product and the electrosurgical unit for other devices and completed the procedure. There was no repair of patient injury regarding this report.
Patient Sequence No: 1, Text Type: D, B5
[12099156]
The subject device was returned to omsc for investigation. The investigation confirmed that the cable broke near a code plug. The cable core was burnt and the broken out section was discolored. Omsc was informed that the user facility had used the subject device for nearly 10 years. Omsc assumes that bending load was put on the cable repeatedly over long periods and it caused the breakage of the cable core. In addition, the user facility continued to use the subject device with the cable core broken, it caused this event. This report is being submitted as a medical devic report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2014-00310 |
| MDR Report Key | 3958438 |
| Report Source | 05,06 |
| Date Received | 2014-06-13 |
| Date of Report | 2014-05-19 |
| Date of Event | 2014-05-16 |
| Date Mfgr Received | 2014-05-19 |
| Date Added to Maude | 2014-07-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 26425177 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A CORD |
| Generic Name | A CORD |
| Product Code | FFZ |
| Date Received | 2014-06-13 |
| Returned To Mfg | 2014-05-23 |
| Model Number | MH-969 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 12-8507 JA 12-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-13 |